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Hybrid vs Non-Hybrid ESD for Colorectal Lesions (SHORT-ESD Trial)

N/A

Recruiting

Led By Dennis Yang, MD

Research Sponsored by AdventHealth

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Non-pedunculated polyps measuring ≥20 mm in lateral diameter by endoscopic estimation

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

SHORT-ESD Trial Summary

This trial will compare two ways of doing a surgery to remove colorectal polyps. One way is called hybrid ESD and the other is non-hybrid ESD. They will compare how long the surgery takes and how safe and effective each method is.

Who is the study for?

This trial is for adults with large, non-pedunculated colorectal polyps (≥20 mm). Candidates must be able to give informed consent and be scheduled for a colonoscopy to remove these polyps. It's not suitable for pregnant women, those with severe blood clotting issues, or anyone who can't have anesthesia.Check my eligibility

What is being tested?

The study compares two methods of removing large colorectal polyps: hybrid ESD and non-hybrid ESD. With 60 patients participating, the main focus is on which method takes less time while also looking at safety and effectiveness.See study design

What are the potential side effects?

While specific side effects are not listed here, endoscopic procedures like ESD may cause discomfort, bleeding, infection risk or rarely perforation of the colon wall.

SHORT-ESD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My polyp is not stalk-like and is at least 20 mm wide.

SHORT-ESD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

• The primary endpoint is to compare procedural time between hybrid vs non-hybrid ESD.

Secondary outcome measures

Complete (R0) resection rate

Completeness of resection

ESD technical difficulty

+4 more

SHORT-ESD Trial Design

2Treatment groups

Active Control

Group I: Hybrid ESDActive Control1 Intervention

Hybrid ESD is a modified ESD technique that uses snare-assisted resection as part of the procedure. With hybrid ESD, a circumferential mucosal incision followed by limited submucosal dissection is performed. Following this, a snare is placed around the lesion, slowly closed to allow resection by traversing the submucosal space

Group II: Non-Hybrid ESDActive Control1 Intervention

A partial or complete circumferential mucosal incision will be performed to expose the submucosa around and underneath the polyp. Endoscopic resection will then proceed via conventional ESD, submucosal tunneling or pocket technique.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

AdventHealthLead Sponsor

107 Previous Clinical Trials

29,519 Total Patients Enrolled

Dennis Yang, MDPrincipal InvestigatorAdventHealth Orlando

6 Previous Clinical Trials

2,056 Total Patients Enrolled

Media Library

Hybrid ESD Clinical Trial Eligibility Overview. Trial Name: NCT05347446 — N/A

Colorectal Lesions Research Study Groups: Hybrid ESD, Non-Hybrid ESD

Colorectal Lesions Clinical Trial 2023: Hybrid ESD Highlights & Side Effects. Trial Name: NCT05347446 — N/A

Hybrid ESD 2023 Treatment Timeline for Medical Study. Trial Name: NCT05347446 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the enrollment capacity of this clinical trial?

"Affirmative. According to clinicaltrials.gov, this healthcare experiment is currently recruiting candidates after being posted on May 9th 2022 and updated August 29th 2022. 60 patients must be procured from 3 distinct medical centres."

Answered by AI

Are there currently any opportunities to partake in this clinical trial?

"Accurate. The clinical trial's information hosted on the website of clinicaltrials.gov states that, as of August 29th 2022, this study is still recruiting participants since its initial posting date back in May 9th 2022."

Answered by AI

Recent research and studies

EndoscopyJournal

Curriculum for Endoscopic Submucosal Dissection Training in Europe: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement

Pimentel-Nunes, Pedro, Mathieu Pioche, Eduardo Albéniz, Frieder Berr, Pierre Deprez, A. Ebigbo, Pieter Dewint, et al.. 2019. “Curriculum for Endoscopic Submucosal Dissection Training in Europe: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement”. Endoscopy. Georg Thieme Verlag KG. doi:10.1055/a-0996-0912.

Gastrointestinal EndoscopyJournal

Clinical Outcomes After Endoscopic Submucosal Dissection for Colorectal Neoplasia: A Systematic Review and Meta-analysis

Fuccio, Lorenzo, Cesare Hassan, Thierry Ponchon, Daniele Mandolesi, Andrea Farioli, Alessandro Cucchetti, Leonardo Frazzoni, et al.. 2017. “Clinical Outcomes After Endoscopic Submucosal Dissection for Colorectal Neoplasia: A Systematic Review and Meta-analysis”. Gastrointestinal Endoscopy. Elsevier BV. doi:10.1016/j.gie.2017.02.024.

EndoscopyJournal

Hybrid Endoscopic Submucosal Dissection (ESD) Compared with Conventional ESD for Colorectal Lesions: A Systematic Review and Meta-analysis

McCarty, Thomas R., Ahmad Najdat Bazarbashi, Christopher C. Thompson, and Hiroyuki Aihara. 2020. “Hybrid Endoscopic Submucosal Dissection (ESD) Compared with Conventional ESD for Colorectal Lesions: A Systematic Review and Meta-analysis”. Endoscopy. Georg Thieme Verlag KG. doi:10.1055/a-1266-1855.

EndoscopyJournal